Tuesday, 10 April 2012

Good Winds From FDA

The U.S. Food and Drug Administration (FDA) published yesterday (April 9, 2012) in YouTube a video entitled "Innovation Pathway at FDA."

Personally I really like the video and especially the positive message it conveys. Here in my blog I give my Sincere Congratulations to the FDA by the video, and especially by the highly positive message it sends.

This message is a very strong set of clear positive signs of optimism, hope, constructive spirit, innovative spirit, proactive and highly dynamic attitude announced to the world.

As far as I know, FDA is among their counterparts around the world an entity with an unquestionable credibility and effectiveness. My perception is that FDA is the reference with respect to regulations in the areas it is responsible.

However, FDA has been discussed in the most recent years with destructive attacks and comments. For example:
  • Apparently innocent criticism;
  • Explicit accusations of not updating (or updating very slowly) its regulations when confronted with new challenges brought by an emerging new reality which includes the requirement for innovation and new and emerging sciences and technologies;
  • Unfounded conspiracy theories which proliferate throughout the Internet;
  • Sensationalist news trying to undermine the credibility of this organization.

Some of these attacks had eventually caused some abrasion on the image of FDA as an organization.

Therefore, FDA needed to launch a campaign containing a very strong message of positivism, optimism, hope and confidence addressed to the world.

The reality has changed in recent years. It is a fact that reality has changed and will change constantly. Thus, FDA and similar organizations must adapt to new realities, new paradigms and the requirements they entail.

But what really happened in the most recent years that really made ​​this change and therefore lead to attacks on FDA and similar organizations, and consequently the release of this video?

Several changes took place.

Firstly, the counterfeit medicinal products began to proliferate in practically the entire world. The counterfeit drugs have become a real scourge in terms of public health and a threat to the pharmaceutical industry.

Moreover, nanoscience and nanotechnology grew and developed at an impressive speed.

Similarly, nanomedicine grew and developed at a considerable speed. Nanomedicine gained critical mass and is proving to have potential to contribute constructively to improve medicine and biomedicine. This is just the beginning. Many more discoveries are to be announced and to a higher speed.

Likewise also grown and developed the applications of nanotechnology-based products in the food & beverages sector. This includes not only food, but also packaging and manufacturing processes.

With the fast development of nanotechnology with applications in medicine (nanomedicine) and in the food & beverages industry, have also emerged real risks associated with toxicity, both environmentally and in terms of public health. These risks are directly related to nanoengineered nanoparticles (nanoparticles intentionally modified by humans for the fulfilment of certain specific purposes). Scientific studies show that these nanoparticles (in opposition to naturally occurring nanoparticles) present the greatest risks to the environment and public health, with respect to toxicity.

Anyway, regulating with quality and adjusted to the real needs of today's society (especially regarding nanotechnology-based health products and food & beverages) is an enormous task, having a complexity of unique proportions. I would say, of historic proportions. It is a complicated challenge and only give good results if integrated, coordinated, standardized and implemented with much committed collaboration with different players, such as innovators, scientists, R&D institutions, universities, industries, health professionals, consultants, IT professionals and many more players.

It is notorious that the video puts much emphasis on technological innovation and collaboration. It is an extremely strong reinforcing of confidence message. In my opinion this message is fully justified, to calm down conspiracy theories and media sensationalism.

This version was published on April 11, 2012, since the original one was removed.

In these areas of science and technology, the worst that can happen is a lack of regulation, which causes a gray zone, providing opportunities to bad professional journalists to make pieces of questionable quality, thus generating fears, suspicions and unfounded conspiracy theories.

FDA is really working hard. I did not learn that with this video. I had already noticed with various press releases issued recently, mainly during the year of 2011 and during the current year. This video just confirmed what I already knew.

However, the ordinary citizen, who is not involved in these matters, did not know. Through this video, the ordinary citizen gets to know.

The tasks that FDA faces are of odd proportions and dimensions absolutely gigantic in the history of our civilization. I can only wish the greatest success to FDA and give them strength.

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